bistos BT-500 User Manual

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P/N : 500-ENG-OPM-EUR-R07

BT-500

Infant Incubator

BT-500

Keep this manual for future reference

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BT-500 Operation Manual 1

P/N : 500-ENG-OPM-EUR-R07

Bistos Co., Ltd.

2018,03

Proprietary Material

Information and descriptions contained in this manual are the property of Bistos Co., Ltd. and may not be copied, reproduced, disseminated, or distributed without express written per mission from Bi st os Co., Ltd

Informatio n f urni shed b y Bi sto s Co., Ltd is believed to be accurate and reliable. However, no responsibility is assumed by Bistos for its use, or any infringe ment s of pa tents or ot her righ ts of third parties that may re sult fro m its use. No license is granted by implication or otherwise under any pa tent or patent rig hts of Bistos.

Revision R07 Mar,2018

7th FL., A Bldg., Woolim Lions V alley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea

Telephone: ++82 31 750 0340 Fax: ++82 31 750 0344

Printed in Korea

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Table of Contents

1. SAFETY ............................................................................................ 4

1.1 Instructions for the Safe Operation and Use of the BT-500 ................................ 4

1.2 W a rni ngs ............................................................................................................. 5

1.3 Shockh azards ................................................................................................... 12

1.4 General precaution on environment .................................................................. 13

1.5 Definitions and symbols ................................................................................... 15

2. INTRODUCTION .......................................................................... 16

2.1 General .............................................................................................................. 16

2.2 Breif Device Description .................................................................................. 16

2.3 Intended Use ..................................................................................................... 16

2.4 Operating Principles.......................................................................................... 16

2.5 Essential performance ....................................................................................... 17

2.6 Options and Accessories ................................................................................... 17

2.7 Appearance of BT-500 ...................................................................................... 19

2.7.1 BT-500 Front view .................................................................................................. 19

2.7.2 BT-500 Front view Detail ....................................................................................... 20

2.7.3 BT-500 Rear view ................................................................................................... 20

2.7.4 BT-500 Side view .................................................................................................... 21

2.8 Description of each part .................................................................................... 22

2.8.1 Control shell ............................................................................................................ 22

2.8.2 Hood ....................................................................................................................... 23

2.8.3 Mattress tray ........................................................................................................... 23

2.8.4 Stand ....................................................................................................................... 24

3. INSTALLATION & CONNECTION ........................................... 25

3.1 IV pole Assembly .............................................................................................. 26

3.1.1 IV Extenal Monitor ................................................................................................ 27

3.1.2 IV plate .................................................................................................................. 28

3.1.3 IV ringer ploe ......................................................................................................... 29

3.2 Air Filter Assembly ........................................................................................... 30

3.3 Connection of Power and Cable ........................................................................ 31

3.3.1 Power Connec t i on .................................................................................................. 31

3.3.2 Cable Connection ................................................................................................... 31

3.3.3 Sensor Module C onnection .................................................................................... 32

3.4 Placement Infant ............................................................................................... 32

3.5 Movement and Innstallation ............................................................................. 32

4. OPERATION .................................................................................. 34

4.1 System Start-up ................................................................................................. 34

4.2 LED................................................................................................................... 36

4.3 Key and knob operation .................................................................................... 37

4.3.1 Key......................................................................................................................... 37

4.3.2 Knob ...................................................................................................................... 37

4.4 Displays ............................................................................................................ 38

4.5 Temperature Measurement and Control ............................................................ 40

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4.6 Humidity Measurement and Control ................................................................. 42

4.7 O2 Measurement ............................................................................................... 43

4.8 Weighting Scale Measurement .......................................................................... 44

4.9 SpO2 and PR(pulse rate) Measurement ............................................................ 44

4.10 Menu functions ............................................................................................... 44

4.11 Pulse Oximeter ................................................................................................ 50

4.12 External Monitor ............................................................................................. 53

4.13 Shut down ....................................................................................................... 55

4.14 Calibration of O2 module ............................................................................... 56

5. ALARMS ......................................................................................... 58

5.1 System alarms ................................................................................................... 58

5.2 Temperature alarms ........................................................................................... 59

5.3 Humidity alarms ............................................................................................... 61

5.4 Oxygen alarms .................................................................................................. 61

5.5 Weighting Scale alarms ..................................................................................... 61

5.6 Alarm self-test ................................................................................................... 62

6. CLEANING & MAINTENANCE ................................................. 63

6.1 General cleaning method and precuations ........................................................ 63

6.2 Hood ................................................................................................................. 64

6.3 Shell, Sensor module, Scale module, Basket .................................................... 64

6.4 Water tankt ........................................................................................................ 64

6.5 Skin temper ature sensors and SpO2 sensors

6.6 Drain of residual water...................................................................................... 65

6.7 Regular Inspection ............................................................................................ 66

6.8 Battery Replacement and Disposal ................................................................... 67

6.9 Disposal of the BT-500 ..................................................................................... 67

..................................................... 65

7. SPECIFICATION........................................................................... 68

8. TROUBLESHOOTING ................................................................. 72

8.1 General Checking ............................................................................................. 72

8.2 Alarm Message Checking ................................................................................. 72

9. MANUFACTURER’S DECLARATION ..................................... 75

9.1 Electromagnetic emissions ................................................................................ 75

9.2 Recommended separation distances between portable and mobile

RF communications equipment and the EUT ................................................... 75

9.3 Electromagnetic immunity ................................................................................ 76

WARRANTY ...................................................................................... 78

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Be informed that it may cause serious injury or death to

“WARNING” sign.

CAUTION

Be informed that it may cause no harm in life but lead to

Be informed that it may cause serious electrical shock to

against the “SHOCK HAZARD” sign.

Section 1

Safety

1.1 Instructions for the Safe Operation and Use of the BT-500 Incubator

 Examine the incubator and any accessories periodically to ensure that the

cables, line cords and instruments do not have visible evidence of damage that may affect patient safety or performance. The recommended inspection interval is once per week or less. Do not use the incubator if there is any visible sign of damage.

 Only the AC line cord sup plied with the BT-500 is approved for use with the

Unit.

 Do not attempt to service the BT -500 incubator. Only qualified service

personnel by Bistos Co., Ltd. should attempt any need e d internal servicing.

 The BT-500 is not specified or intended for operation during the use of

defibrillators or during defibrilla tor discharge.

 The BT-500 is not specified or intended for operation in the presence of

electrosurgical equipment.

 The BT-500 is not specified or intended for operation in conjunction with any

other type of equipment except the specific devices that have been identified for use in this Operator’s Manual.

 Perform periodic safety testing to insure prope r patient safety. This should

include leakage current measurement and insulation testing. The recommended testing interval is once per year.

 Do not operate the BT-500 incubator if it fails to p a ss the power on self-test

procedure.

WARNING

SHOCK HAZARD

the patient, property damage, material losses against the

injury against the “CAUTION” sign.

the patient or operator, property damage, material losses

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WARNING

Thoroughly read and und erstand the manual prior to use of the

Higher incubator relative humidity at any given temperature

1.2 Warnings



incubator. Failure to do so could result in personal injury or equipment damage.)

 Incubator misuse may re sult in harm t o an infant. Only properly

trained personnel should use the incubator as directed by an appropriately qualified attending physi cian aware of currently known risks and benefit s .

 Use of accessories other than those listed and approved for use in

this product as original or repla c ement items may result in increased emissions or decreased immunity.

 The total electrical current leakage of all items powered through

the incubator, including devi ces on the outlet strip, must be less than 300uA for 120V AC/ 100V AC systems and less than 500uA for 230V AC systems. Otherwise, personal injury or equipment damage could occur.

 The use of ac cessory equipment not complying wit h the

equivalent safety requi rements of this equipment may lead to a reduced level of safety of the resulting system. Consider the use of the accessory in the patient’s vicinity and evidence that the safety certifications of the accessory have been performed in accordance with the appropriate International Electrotechnical commission (IEC) 60601-1 harmonized national standard. Personal injury or equipment damage could occur.

 Devices connecting to the serial data port must be compliant with

EN 60601-1-2, the EMC requirement for Medical Devices. Failure to do so could result in personal injury or equipment damage.

 Medical electrical equipment needs special precautions regarding

EMC and needs to be installed and put into service according to the EMC information provided in thi s manual. In addition, portable and mobile RF communicatio ns equipment can effect medical electrical equipment.

 The equipment shall not be used adjacent to or stack with other

devices unless verification of normal operation in the configuration in which it is to be used can be achieved.

 Use only Bistos recommended fuel cells for proper operation.

Failure to do so could result in personal injury or equipment damage.



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decreases an infant’s evaporative heat loss, and may cause an

increase in the infant temperature. Routinely monitor the infant’s rectal and/or axillary temperature according to the attending physician’s orders or Nursery Standing Orders. Failure to do so could result in personal injury.

 Higher relative humidity will, at any given time, decrease an

infant’s evaporative water loss, and may cause an increase in infant temperature. This effect is greatest n very low birth-weight, premature infant s . The attending physician should prescribe Temper ature Control mode, temperature setting, and humidity output level setting. Routinel y monitor the infant’s rectal and/or axillary temperature according to the attending physician’s ord er s or Nursery Standing Orders. Failure to do so could result in personal injury.

 Fill the reservoir to the Maximum Filing Limit line. Do not

overfill. Water spillage may result, and personal injury could occur.

 Use distilled water only (<10 ppm total dissolved solids). The

use of sterile water is not acceptable. Equipment damage could occur.

 For proper operation of the incubator, use only skin temperature

probes from Bistos Co. Ltd. Using other probes could result in personal injury or equipment damage.

 Never place the skin temperature probe under the infant or use it

rectally. Personal injury could occur.

 BT-50 0 cannot differentiate between an increase in core

temperature with a cold skin (fever) and a low core and skin temperature (hypothermia). The temperature of the infant is monitored separately.

 When in skin mode, the skin tempera t ure probe must be in dire ct

contact with the skin to provide acc ura te monitoring of the infant’s skin temperature. When in skin mode, failure to maintain direct skin contact can result in overheat ing. Routinely check the infant’s condition for correct sensor attachment, and feel the infant’s skin for signs of overheating.

 When an x-ray is taken through the hood, the hood could show

up on the x-ray as a radiolucent shadow and could result in incorrect diagnosis.

 Do not use in the presence of flammable anesthetics. Personal

injury or equipment damage could occur.

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Keep matches, and all other sources of ignition, out of the room



in which the incubator is located. Textiles, oils, and other combustibles are easily ignited a nd burn with great intensity in air enriched with oxygen. Personal injury or equipment damage could occur.

 Small quantities of flammable agents, such as ethyls and alcohol,

left in the incubator may cause a fire in connection with oxygen. Personal injury or equipment damage could occur.

 A fire and explosion hazard exists when performing cleaning or

maintenance procedures in an oxygen-enriched environment. Make sure tha t oxygen sup ply is turned Off and the oxygen hose to the incubator is disconnected when performing cleaning and maintenance procedures. Turn off or disconnect oxygen supplies during periods of non-use. Failure to do so could result in personal injury or equipment damage.

 If it is necessary to administer oxygen in an emergency, notify the

attending physician immediate ly. Failure to do so could result in personal injury or equipment damage.

 Improper use of supplemental oxygen may be associated with

serious side effects including blindness, brain damage, and death. The risks vary with each infant. The qua lified attending physic ian should prescribe the method, the concentration, and the duration of oxygen administrati on.

 Administration of ox ygen may increase the noi s e level for the

infant wi t hin the infa nt incubator.

 An oxygen analyzer shall be used separately when oxygen is

delivered to the infant.

 Measure the oxygen concentrations to verify delivery of the

prescribed oxygen concentration. Failure to do so could result in personal injury or equipment damage.

 If the patient’s arterial oxygen levels cannot be maintained when

the oxygen control setting is set to maximum, the attending physician should prescribe alternate means of oxygenation. Failure to do so could result in personal injury or equipment damage.

 The oxygen c oncentration inspire d by an infant does not

accurately determine the partial pressure of oxygen(pO

) in the

blood. When deemed advisable by the attending physician, measure blood pO

by accepted clinical techniques. Failure to do

so could result in personal injury or equipment damage.

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Disconnect the incubator from the hospital oxygen source when

Phototherapy units located too c lose to the incubator may affect



oxygen is not in use. Failure to do so could result in personal injury or equipment damage.

 As oxygen use increases the danger or fire, do not place auxiliary

equipment that produces sparks in an incubator. Personal injury or equipment damage could occur.

 Use of anesthetic agents can interfere with oxygen analyzer

accuracy.

 Inspect gas/oxygen service components at regular service

intervals for signs of corrosion or damage. Failure to do so could result in pe rsonal injury or equip ment damage.

 A dirty air intake micro filter could affect performance or cause

carbon dioxide(CO2) build-up. Ensure that the filter is checked on a routine basis commensurate with local conditions. Particularly, if the unit is used in an unusually dusty environment, more frequent replacements may be necessary. Failure to do so could result in infant injury or equipment damage.

 After each change of oxygen flow, allow at least 30 min to

achieve new concentrations. Failure to do so could result in personal injury or equipment damage.

 Compressed gas cylinders, such as oxygen cylinders, can be come

hazardous projectiles if the gas is released rapidly due to damage or other causes. Securely fasten the cylinder. Failure to do so could result in personal injury or equipment damage.

 Oxygen levels within t he incubator hood environment may be

affected when the access doors or access panels are opened. Make sure all hood access door gaskets and tubing ports are properly installed. Any open gaps in the incubator hood may reduce the incubator’s internal oxyge n. Personal injury could occur.

 Make sure all hood access door gaskets and tubing ports are

properly installed. Any open gaps in the incubator hood will reduce the incubator’s internal relative humidity. Personal injury or equipment damage could occur.

 The use of infant seats, or other accessories within the incubator

that can alter the airflow pattern, may affect temperature uniformity, temperature variability, the correlation of the incubator temperature reading to center mattress temperature and infant skin temperature. Personal injury could occur.



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hood wall temperature, incubator hood temperature, and infant

space, check that the patient is secured safely in the unit and

skin tempera ture. Personal injur y of equipment damage coul d occur.

 Phototherapy lamps placed over the top of the incubator hood

may interfere with upward travel of the vertical height adjustable stand. To prevent this interference, always remove the phototherapy lamp prior to positioning the stand.

 If airflow passages are not kept clear of obstructions, such as

blankets and stuffed animals, during clinical usage, patient safety and incubator performance may be compromised.

 To avoid overheating the infant due to direct rad iation, do not

position the incubator in direct sunlight or under other sources of radiant heat.

 Do not place surgical covers or blankets over the infant and warm

air curtain or side vents simultaneo usly. This may cause heatinduced injury and burn s .

 To prevent accidental disconnection, secure all patient leads,

infusion lines, and ventilator t ubing to the mattress with sufficient excess length to allow for the full range of mattress height adjustment.

 Only connect equipment to the serial port that complies with the

relevant IEC standard; and use data cables with plastic body connectors.

 Do not raise the hood at any time while the infant is in the

incubator. Gain access to the infant by the access panels and access doors. Failure to do so could result in personal injury or equipment damage.

 When the front access panel (or optional rear) is open, the

temperature display may not accurately reflect the incubator temperature. Do not leave the front access panel (or optional rear) open longer t han essential. Persona l injury could occur.

 Positively secure all access panel latches to avoid accidental

opening, Failure to do so could result in personal injury or equipment damage.

 For infant safety, do not leave the infant unattended when the

access panels are open. Personal injury could oc cur.

 Always use two people when moving the incubator and patient

together. When moving the incub at o r wit hi n the sa me flo o r

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either remove or secure all loose system components to prevent

particularly with the ho od open. Personal injury or equipment

possible patient injury or equipment damage. If the move involves varying floor heights or a complete floor level change (i.e. thresholds, ramps, elevators), remove all items either not being used or not necessary for the move, lower the VHA, IV poles and shelves to their lowest po sitio n, place all drawers in their locked state, and remove all accessories from the front and rear rail position.

 Never place objects taller than the top of the wheel casters

beneath the incubator stand. Placement of objects there could interfere with the stability of the vertical height adjustable stand. Personal injury of equipment damage could occur.

 To avoid possible tip-over or damage to adjacent carts, IV stands,

shelves, etc., keep at least a 12” (30 cm) perimeter area clear around the vertical height adjustable stand.

 For optimum incubator stabilit y, always lock all stand wheels, Do

not leave the unit unatte nded when parking on an incline. Failure to do so could result i n personal injury or equipment damage.

 When raising or lowering the incubator, the operator should

ensure that both equipment and appendages are clear of the unit’s travel path. Patient and incubator connections must also be checked before adjusting the incubator height. Never place any objects on top of the drawer assembly and always check before lowering the VH that there is sufficient clearance between the incubator and stand assembly. Do not raise or lower the unit while installing or removing med ic a l gas tanks from the tank holder assembly. Failure to do so could result in personal injury of equipment damage.

 The UART port is for debugging purposes only. It does not allow

connectio ns with other d evices.

 Prior to placing the infant in the inc ubator, pre-warm the

incubator to the temperature prescribed by the attending physician, or according to nursing protocol.

 Only one monitor shelf should be used per incubator. When using

the monitor s helf, always place the monitor in the center of the shelf, ensure that the monitor fits within the border of the shelf, and avoid stacking monit ors on the shelf. Personal injury o r equipment damage could occur.

 Attach the incubator to the stand or the vertical height adjustable

stand using the bolts provided. Failure to do so could result in the incubator separating from the stand if sufficiently tilted,

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damage could occur.

Inaccurate measurements may be caused by excessive patient

 This product has been validated with the accessories and options

listed in this manual and found to c omply with all relevant safety and performance requirements applicable to the device. It is therefore the responsibility of that person or organization who makes an unauthorized modification, or incorporates an unapproved attachment to the device, to ensure that the system still complies with those requirements.

 A pulse oximeter should NOT be used as an apnea monitor

 Pulse rate measurement is based on the optical detection of a

peripheral flow pulse and therefore may not detect certain arrhythmias. The pulse oximeter should not be used as a replacement or substitute for ECG based arrhythmia analysis.

 A pulse oximeter is an early warning device. Use lab co-oximeter

to completely understand the p atie nt’s condition.

 Do not use the MS board pulse oximeter in the presence of

flammable anesthetics or other flammable substance in combination with air, oxygen enriched environments, or nitrous oxide.

 Do not remove the monitor cover except to replace the battery.

An operator may only perform maintenance procedures specifically described in this manual. Refer servicing to Masimo in repair of this equipment.

 Leakage current must not exceed 100 microamperes; measure

when an external device is connected to the serial port.

 Do not use Masimo oximetry sensors during MRI scanning as it

could potentially cause burns.

 Inaccurate measurements may be caused by incorrect application

or use.

 Inaccurate measurements may be caused by significant levels of

dysfunctional hemoglobin (HbCO or MetHb).

 Inaccurate measurements may be caused by intravascular dyes

such as indocyanine gre en or methylene blue.

 Inaccurate measurements or loss of pulse signal may be caused

by excessive illumination.



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movement.

Tissue damage can occur due to incorrect placement of sensor.

SHOCK

Unplug the unit from its power source prior to cleaning or

 Inaccurate measurements may be caused by venous pulsation.

 Inaccurate measurements or loss of pulse signal may be caused

by placement of a sensor on an extremity with a blood pressure cuff, arterial catheter or intravascular line.

 The MS board pulse oximeter can be used during defibrillation,

but the readings may be inaccurate for a short time.

 Loss of pulse signal can occur when t he sensor is too tight.

 Loss of pulse signal can occur when t he patient has hypotension,

severe vasoconstriction, severe anemia, or hypothermia.

 Loss of pulse signal can occur when there is arterial occlusion

proximal to the sensor.

 Loss of pulse signal can occur when the patient is in cardiac

arrest or is in shock.

 Use only Masimo sensors for SpO2 measurements.



1.3 Shock hazards



HAZARD

maintenance. For units equipped with an uninterruptible power supply(UPS) system, also remove the battery pack prior to cleaning or maintenance. Failure to do so could result in personal injury or equipment damage.

 Some chemical cleaning agents may be conductive and leave a

residue that may permit a build-up of conductive dust or dirt. Do not allow cleaning agents to contact electrical components, and do not spray cleaning solutions onto any of these surfaces. Personal injury or equipment damage could occur.

 To ensure grounding reliability, plug the AC power cord only into

a properly grounded 3-wire hospital-grade or hospital-use outlet. Do not use extension cords. If any doubt exists as to the grounding connection, do not operate the equipment. Personal injury or equipment damage could occur.

 Do not expose the unit to excessive moisture that would allow for

liquid pooling. Personal injury or equipment damage could occur.

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Due to the risk of electrical shock hazard, only qualified

cord coming directly from the pedestal /stand.



personnel with appropriate service documentation should service the unit.

 Batteries can present a risk of electric shock. The following

precautions should be taken when working on batteries: remove watches, rings or other metal objects; use tools with insulated handles.

 The total power of all equipment connected to the convenience

outlet strip on the pedestal / stand must me within the electrical requirements shown on the rear of the pedestal / stand. Otherwise, personal injury or equipment damage could occur.

 Make sure the Building power source is compatible with the

electrical specifications shown on the column of the pedestal / stand and on the incubator. Failure to do so could result in personal injury or equipment da mage.

 To prevent equipment damage or accidental power

disconnections, do not plug an incubator power cord directly to an AC wall socket when the incubator is mounted on a pedestal /stand. Always provide power to the incubator by using the power

1.4 General precaution on environment

Do not keep or operate the equipment under the environment listed below.

Avoid placing in an area exposed to moisture. Do not touch the equipment with wet hand.

Avoid placing in an area where there is a high variation of temperature. Operating temperature ranges from 20°C to 30°C. Operating humidity ranges from 0% to 95%.

Avoid placing in an area where there is an excessive humidity rise or ventilation problem.

Avoid exposure to direct sunlight

Avoid in the vicinity of Electric heater

Avoid placing in an area where there is an excessive s hock or vibration.

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Symbol

Description

Used to identify safety information.

During the operation, do not disconnect any cable.

Skin temperature senso r #1, to be c onnected to infant’s abdomen for baby (controlled) mode

IPX0 Non-protected against ingress of water with harmful effects. (Device)

IPX1 Protected against the vertically dripping water

(Skin temperature sensor_2EA)

IPX2 Protected against the dripping water

(SpO2 sensor)

IPX6 Protected against the power ful jetting

(Foot switch_2EA)

This symbol indicates the authorized representative in the European

Do not disjoint or

it.

Power off when the

damaged.

Avoid placing in an area where chemicals are stored or where there is in danger o f gas leakage.

disassemble the equipment. BISTOS Co., Ltd. does not take responsibility of

1.5 Definitions and symbols

Be well-known this information thoroughly before using BT-500.

Indicate the warning for hot surface.

Type BF Applied part

Refer to operation manual. Read manual before placing the device.

Avoid dust and especially metal material into the equipment.

equipment is not fully installed. Otherwise, the equipment could be

Skin temperature sensor #2, to be connected to other than infant abdomen

IPX0

IPX1

IPX2

IPX6

Indicates the weight limit

This symbol indicates the manufacturer.

This symbol indicates the serial number of the device.

Community of manufac turer.

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imitation for operation, transport and

This symbol indicates the compliance with the essential requirements and

This symbol indicates to not dispo se the device together with unsorted

This symbol indicates to keep the device dry.

This symbol indicates to keep the correct upright position on the tran sport package.

This symbol indicates the device is fragile.

This symbol indicates the temperature limitation for operation, transport and storage.

This symbol indicates the h umidity l storage.

This symbol indicates the packing material is recyclable.

External Signal IN/OUT Port

provisions of the Medical Device Directive 93/42/EEC as amended by 2007/47/EEC.

municipal waste(for EU only). The solid bar symbol indicates that mains adapter is put on the market after 13 August 2005.

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Section 2

Introduction

2.1 General

This chapter provides a general description of the BT-500 infant incubator including.

 Brief Device Description  Pr oduct Features  Model Configurations

2.2 Brief Device Description

A mains electricity (AC-powered) unit designed to provide an enclosed controlled

environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature. It typically consists of a clear removable plastic hood with a mattress. It typically includes a means to warm the infant such as providing heated air; temperature controls that work automatically either by measuring the air temperature or through a temperature sensor attached to the infant skin; and hu midity controls. The device is intended to use in a hosp ital.

2.3 Intended Use

BT-500 is an infant incubator for non-invasively measuring and showing graphically

humidity, air temperature, skin temperature, O2 Module, weight and SpO2. This data is intended to aid the maintaining life o f a premature baby or a precocious baby under 2kgs. This device is for use only by trained medical personnel located in hospital. Also this device can be used in the all departments of the hospital which offers a neonatal care service such as NICU(Neonatal Intensive Care U nit), special nursery unit and pediatrics.

2.4 Operating Principles

- Air and skin temperature measurement and Control: Internal cartridge heater raises the

temperature. The infant environmental temperature value is determined by air a skin temperature that is measured by the sensor module. Through the main fan, the air is circulated within the hood and adjusts the temperature.

- Humidity measurement and control: The steam of humidity module vaporizes the water

particles. It Adjust the humid ity mixed with air withi n the hood. Sterilize d by heating the water to 100℃.

- O2 Module(Optional): It i s available to control t he oxygen conc entratio n in the hood when

putting the module option of oxygen concentration.

- SpO2 measurement (Optional): The probe sensor is wear at the end of an infant’s finger . By

measuring the intensity of reflected light, depending on the concentration of dissolved oxygen in the blood determines the oxygen sa turation.

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WARNING

Do not use the skin temperature cont rol on babi es who are in shock

Picture

Name

Description

Qty

- Pulse rate measurement(SpO2): During the heart beats, the infrared light is fro m the light

source.

It is on the arteriole, such as fingers. The intensity of the light is r eflected to the sensor is measured.

2.5 Essential performance

 Air temperature measurement and incubator air temperature control.  Skin temperature measurement and infant Skin temperature control.  Humidity measurement and control inside the incubator.  An alarm occurs if the difference between the set temperature and the control

temperature is more than a certain level.

 System must remain in a safe condition acc. IEC 60601-1, IEC 60601-2-19

or who have h igh temperatures

2.6 Options and Accessories

Control shell

(Standard)

Hood

(Standard)

Fixed Stand

(Standard)

Basket

(Optional)

Basket Partition

(Optional)

Sensor module

(Standard)

Hold up the hood and be composed

with instruments and pa rts that co ntrol

the temperature and humidity

Made of double framed clear acrylic

panel to watch inside, and to minimize

heat loss

Movable incubator cradle with wheels 1ea

Storage of medical equipment and

items which infa nt ne ed s

Partition of Basket 1ea

Measures temperature and humidity

inside the hood and infant’s body

temperature

1ea

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Accommodate infant stably with

Mattress tray

(Standard)

mattress

(Standard)

Skin

temperature

sensor

(Standard)

IV-pole

(Optional)

AC power code

(Standard)

External LCD

Monitor

(Optional)

Baby desk with X-ray tray 1ea

bouncy mattres s

Measures infant’s skin temperature 2ea

IV hanger. 1ea

AC Power cord

operating the equipment)

(AC Power cord for

Displays measured values from the

control and video of infant inside the

hood

1ea

CCD Camera

(Optional)

Masimo SpO2

sensor probe

(Optional)

Masimo

Extension for

SpO2 sensor

(Optional)

IV plate

(Optional)

Shelf

(Optional)

Takes video of infant inside the hood 1ea

Measures infant’s SpO2 1ea

Extend sensor cable 1ea

Plate to place items which infant needs 1ea

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Notes;

Lift Stand (Optional)

Weighting

Scale

(Optional)

Movable incubator cradle with wheels

(VHA- Variable Height Adjustable)

Measures Infant’s weig ht

1ea

* The built-in air filter requires periodic replacement to m aintain clean air per iod ic

replacement of the pads according to the maintenance schedule is recommended.

**Oxygen control module is also available as an optional component.

2.7 Appearance of BT-500

2.7.1 BT-500 Front View

Figure 2-1. BT-500 Front view

① Control Shell ② Hood ③ Sensor module ④ Moving Stand ⑤ Basket ⑥ IV pole ⑦ IV plate ⑧ External monitor

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2.7.2 BT-500 Front View Detail

Figure 2-2. BT-500 Front view details

① Console box ② Water tank draw ③ Tilting mecha nism handle ④ Hood handle ⑤ Front access door ⑥ Baby desk with X-RAY Tray ⑦ Weighing scale ⑧ Compatible mattress

2.7.3 BT-500 Rear view

Figure 2-3. BT-500 Rear view

① Rear Access Door ② AC power cord & Connector

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2.7.4 BT-500 Side view

Figure 2-4. BT-500 Left view

① Sensor Module, SpO2 sensor & External Communication port ② Main power switch ③ Main power AC connector ④ Incubator handle

Figure 2-5. BT-500 Right view

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2.8 Description of each part

BT-500 is composed with several parts. The control shell is the part which controls the entire device. To measure the infant’s environment, the sensor module is needed. The hood is used to protect an infant from the exter nal environ ment and maintai n the internal e nvironment of hood to best condition.

2.8.1 Control shell

The control shell part consists of console box and water tank.

Figure 2-6. Control Shell

The water tank has a 1 Liter capacity. The reservoir permits vi sual inspection of the water level. It is located in a drawer in the front of the she ll. When the drawer is cl osed and the latching handle is engaged, the reservoir is connected to manifold. For more information about how to clean, see "Chapter 6 cleanliness and maintenance”

Figure 2-7. Water Tank

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Warning

To prevent accidental disconnection, secure all patient leads, infusion

a. Rotate the pawl latches, and open the front

Weight limit : under 20kg

2.8.2 Hood

The hood of BT -500 is an acrylic material. There is Access door in the front, rear and both sides of hood.

Figure 2-8. Hood front view & Access door / side function

lines, and ventilator tubing to the mattress with sufficient excess length to allow for the full range of mattress height adjustment.

2.8.3 Mattress tray

access panel. b. Pivot the front access panel to the f ull open position (hanging straight down). c. Slide out the mattress tray to the fully extended position (up to 22cm). d. Carefully lean on the mattress tray to ensure it is properly supported and provides a firm infant platform. e. Return the mattress tray. f. Close the front access panel, and rotate both latches until they are ful ly engaged.

Max. to 220mm

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WARNING

When raising or lowering the incubator, the operator should ensure

to do so could result in personal injury of equipment damage.

2.8.4 Stand

BT-500 has two types of stand as fixed and lifting. Following figure s how the fixed s tand.

Figure 2-12. Fixed Stand (Standard)

In case of lifting type, you are able to adjust the vertical h eight using two sets o f up/down arrow on footswitch. (VHA - Variable Height Adjustable) This type is optional. The hei gh t o f the stand can be adjusted if necessary by stepping on an appropriate side of the pedal for height adjus tment.

Figure 2-13. Lifting Stand (Optional)



that both equipment and appendages are clear of the unit’s travel path. Patient and incubator connections must also be checked before adjusting the incubator height. Never place any objects on top of the drawer assembly and always check before lowering the VHA that there is sufficient clearance between the incubators and stand assembly. Do not raise or lower the unit while installing or removing medical gas tanks from the tank holder assembly. Failure

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Section 3

Installation &

Connection

Attention to follow direction for installing BT-500.

 Use this device in 20~30 ℃ of environmental temperature and 0~90 % of

humidity.

 Check the connection of the AC power cord and then use this cord,

 Caution to this device because of easy to break.

 When connec ting AC power cord, connect the one electrical outlet and infant

incubator.

 Install the main body on horizontal location.

 Do not use the electrical cord connected to generate a noise.

 Install away from dust or inflammable material

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No.

Part name

IV ringer pole Assembly

IV plate Assembly

IV External monitor Assembly

Shelf

3.1 IV pole Assembly

The IV poles can be mounted as below. Check each Part name and number

①

②

③ ④

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No.

Qty

Description

1ea

LCD Monitor Ass’y

3ea

Machine Screw, M5x5 , stripper , stain-less steel , (Hexagon wrench 2.5 mm)

1ea

IV LCD PIPE , 25.4mm , stain-less steel

4ea

Machine Screw, M3x12 , pan head , stain-less steel

1ea

IV LCD FRAME

2ea

Lock washer, M6 , stain-less steel

2ea

Screw, M6x25 , Hex wrench , stain-less steel , (Hexagon wrench 5 mm)

1ea

LCD Monitor Ass’y Cable

3.1.1 IV External monitor

①

②

③

④

⑤

⑥

⑦

⑧

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No.

Qty

Description

1ea

IV PLATE BOLT , Hex wrench , stain-less steel

1ea

IV PLATE

1ea

IV PLATE BUSHING 2T

1ea

IV PLATE SUPPORT 6T

4ea

Machine Screw, M3x12 , pan head , stain-less steel

1ea

IV PLATE POLE ,25mm , aluminum

1ea

IV PLATE FRAME

1ea

Lock washer, M5 , stain-less steel

1ea

Screw, M5x15 , Hexagon head bolt, stain-less steel (Hexagon wrench 4 mm)

2ea

Lock washer, M6 , stain-less steel

2ea

Screw, M6x25 , Hexagon head bo lt , stain-less steel (Hexagon wrench 5 mm)

3.1.2 IV plate

①

②

③

④

⑤

⑥ ⑦

⑧

⑨

⑩

⑪

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No.

Qty

Description

1ea

Ringer Pole

1ea

IV Ringer pipe, 25.4mm , stain-less steel

4ea

Machine Screw, M3x12 , pan head , stain-less steel

1ea

IV LCD FRAME

2ea

Lock washer, M6 , stain-less steel

2ea

Screw, M6x25 , Hexagon head bolt , stain-less steel (Hexagon wrench 5 mm)

3.1.3 IV ringer pole

①

②

③

④

⑤

⑥

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No.

Qty

Description

1ea

Micro Filter

1ea

Filter Cover

2ea

Filter Cover Bolt

WARNING

Air filter exchange period is once in 3 month. Please check

3.2 Air Filter Assembly

①

②

③

④

Total Ass’y



frequently and carefully that it is not dirty.

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WARNING

When inserting or removing the connectors, be careful not to put or

equipment damage.

3.3 Connection of Power and Cable

3.3.1 Power Connection

Connect 110V or 220V AC power cord to power, and connect the code to the power input terminal one side of the body below the BT-500 body. At that time, make sure latch the cord by using the locking device for prevent of unexpected separation. Afterward, it is operated by pushing the power switch lo c ated at the bottom of the front of the device sh own as below. When power is supplied normally, the power indicator LED is lit and Self-test screen appears at the same time.

Figure 3-1. Power Connection

3.3.2 Cable Connection

Connect all probes and cables to the sensor part in the hood and left and rear part of stand

shown as bel ow.



pull the cable by force or twist it. Be sure to confirm the position, direction and shape and to pull lightly the locking metal part of the end of the cable. Failure to do so could result in personnel injury or

Figure 3-2. Cable Connection

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WARNING

Prior to placing the infant in the inc ubator, pre-warm the incubator

according to nursing protocol.

3.3.3 Sensor Module Connection

Connect the sensor module shown as below. Remove the connector of the sensor module.

While pulling the both guide locks, pull the sensor module out of the hood.

Figure 3-3. Sensor Module Connection

3.4 Placement Infant

To place a n infant in the i ncubator, perform the fol lowing:

1) Pre-warm the incubator.

2) Rotate the pawl latches and open the front access door of hood.

3) Place the infant on the center of the mattress carefully.

4) Close the access door and ensure the pawl latches are fully engaged.



to the temperature prescribed by the attending physic ian, or

3.5 Movement and Installation

To move the position of incubator, perform the following:

1) Identify that infant is not in incubator.

2) Turn off all accessories plugged into the stand receptacles and remove accessories and items not in us e during movement.

3) In case of VHA, adjust the stand to its lowest position prior to move the equipment.

4) Coil up the power cord and secure it.

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WARNING

Never move t he incubator when there is an infant in the incubator.

personal injury or equipment damage.

CAUTION

Install the incubator on a horizontal and stable place. Step on the

supply mains.



 Always push or pull the incubator forward or backward in a

straight line along the length of the stand ( from the ends). Lateral or angular movement (across the width) can result in inadvertent tip-over if the wheels encounter any obstacle. Personnel injury or equipment damage could occur.

 Always us e two people when moving the incubator. When moving

the incubator within the same floo r space, And remove or secure all loose system components to prevent possible patient injury or equipment damage. If t he move involves varyin g fl oor height s or a complete floor level change (i.e. thresholds, ramps, elevators), remove all items either not being used or not necessary for the move, lower the VHA, IV poles and shelves to their lowest position, place all drawers in their locked state, and remove all accessories from the front and rear rail position.

 Always close and latch drawers when not in use and particularly

when the incubator is being moved.

 For optimum stability, always lower the incubator to its lo west

position prior to transport. Make sure that items placed on the monitor shelf are properly secured. Failure to do so could result in

To install the BT-500 in desired place, you should lock the two casters on the stand. To lock a caster, lower the stopper on the caster to the locking position. To unlock a caster, raise the stopper.

Figure 3-4. Stand caste rs lock



two stoppers to lock the casters securely. To move the incubator to another place, be sure to unlock the casters.

 The AC power plug is a means to isolate its circuits electrically

from the supply mains on all poles simultaneously. Do not place the device in an area when there is difficult to disconnect from the

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Section 4

Operation

4.1 System Start-up

1) Turn on the power switch in the bott om left of the BT-500 front.

Figure 4-1. Power Switch

2) Then check the follow logo is displayed in the main LCD.

Figure 4-2. Self Test Display

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1) Make sure the system check screen is being output. Make sure each piece of

equipment is functioning properly. The connection may differ depending on the options and modules connected or not.

2) Ensure that the various items properly output to the main display screen of the

product. If the O2 control option has been added to the main display screen it can be changed to control the O2 concentration inside the incubator.

Figure 4-3. Main Display

Figure 4-4 Main display (Setting the O2)

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When alarm situation is activated, using this key you can of f the sound for a certain time. In this case, LED is off

Lock the Ke y, used to unlo ck it. on.

In o

In case of blinking.

This is a control panel of BT-500.

Figure 4-5. Control panel

4.2 LED

The following symbol s are f u nctions and descriptions of LEDs on the control panel.

Symbol Name Description

Mute

Key & LED

Keylock

Key & LED

Override mode

AC power

LED

verride mode, LED is on.

AC power cord is disconnected by accident, LED is

When key is l ocking, LED is

Table 4-1. Function of LED

If the key beep is on, wheneve r you push any keys the beep sounds. To use contr ol p anel, you mus t unloc k the ke y loc k fu nction first. T his is the pro tective method of misuse or unintended operation. To unlock the key locking function, you

should use [ke ylock] key.

When you pus h [keylock] key, LED is of f. Then you

can go into mode setting and setting of co ntrol parameters.

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Symbol

Name

Description

Use this key to select the parameter for set-up. Use this key to s (option : select the

Mode

Use this key to select cont

Use this key to raise the parameter

Down

Use this key to lower the parameter

Use this key to enter the parameter Use this key

Use this key to silent during a period of time in case of the alarm situation.

Use this key to Lock or unlock.

Display window

Action

Description

Push

Reflect setting value.

Push

Select options / Finish selecti ng options

Rotate(CW/CCW)

Shift options and change se tti ng va l ue

4.3 Key and knob operation

4.3.1 Key

Parameter Key

Key

Enter

Key

Menu Key

Mute Key

Keylock Key

elect the temperature, humidity

oxygen concentration)

rol mode.

’s value.

’s value to control mode.

to enable the use of Knob to select menu options.

Table 4-2. Use of Key

4.3.2 Knob

Not only Knob is used for c hanging the setting value, but also it can be used for shifting and changing the Menu options. For changing the setting value, when the setting is complete, setting value is reflected to control by pushing. For using the

purpose o f Menu option, you should [Menu key] Following table shows how to handle knob in each case.

Control

setting value

Rotate CW

Rotate CCW

Table 4-3. Use of Knob

when key locking is rel eased.

+0.1 ℃ or +1 %

-0.1 ℃ or -1 %

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4.4 Displays

BT-500 provides the one display screen and the one dynamic Menu window together.

Figure 4-6 is the ba sic layout of BT-500.

Figure 4-6. Main operation display

① Air temperature r e gion

This region displays the measured air temperature in the hood. Celsius(℃) or Fahrenheit(℉) can be displayed according to set. In case of module failure, connection failure and senor failure is indicated by “--.-”.

Note: In this re gion, current heater p ower is displayed by gauge

② Skin temperature region

This region displays the patient’s skin temperature in the hood. Celsius(℃) or Fahrenheit(℉) can be displayed according to set. The case of module failure, connection failure and senor failure is indicated by “--.-”.

Figure 4-7. Basic screen of Main display (O2 control available)

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Temperature Setting Value

Humidity Setting Value

SpO2 Setting Value

Pulse rate Value

③ Humidity region

This region displays the measured relative humidity in the hood. Correct unit is %RH and % is displayed only.

Note: In this re gion, current water level i s displayed by gauge.

④ Setting region

In this region, according to control mode, especially air mode, user is able to set the

temperature in the hood. In case of skin mode, user is able to set the patient’s skin

temperature in the hood. At this time, equipment doe s not c ontrol the temperature

setting value that is lower than outer temperature. Also user can set the relative

humidity i n the hood.

⑤ SpO2 region

This region displays the lists of items regarding the SpO2. SpO2 value and PR(pulse rate) extracted from SpO2 waveform are displayed with unit(%, bpm). When the signal is not measured, it is indicated as “---”.

⑥ O2 region

This region displays the O2 concentr ation by the % unit in the hood When the O2 sensor has malfunction or disconnection, it is indica te d as “-- ”. When the O2 s ensor reaches the saturating concentration, it is indicated as “**”.

⑦ Scale region

This region displays weight of infa nt. When the scale module has ma lf unc ti on or disconnection, it is indicated as ” -.---”

⑧ Status region

This region displays the Date/Time, patient ID, control mode icon, o ver ride mode icon, Keylock icon, and Sound icon. In control mode, there are air mode and skin mode and configuration color is changed by modes status. In override mode, air mode,

if setting temperature is above 37.1 ℃, skin mod e , if setting temperature is above

37.6 ℃, the setting can be executed with [ keylock] key. In case of sound icon,

Press the [Mute key] situation.

button to pause the alarm sound in case of the alarm

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Air/Skin temperature

Air/Skin temperature Override mode

Following table indicates the function of i con used in the status region.

Icon Name Description

Air mode icon Control mode status : Air mode

Skin mode icon Control mode status : Skin mode

Humidity mode icon Control mode status: Humidity mode

Trend icon Trend indication

O2 icon O2 indication

SpO2 icon SpO2 indication

PR icon Pulse rate indication

Weight icon Weighti ng scale indication

Override mode icon

On.

Key lock icon Key is locking.

Key unlock icon Key input is enable..

Alarm on icon Alarm Sound on.

Alarm off icon Alarm Sound off.

4.5 Temperature Measurement and Control

Measurement: Measurement of air temperature and skin temperature are starting at the same time of BT-500 power on. In case of skin temperature, especially, metal part of skin temperature sensor probe must be attached to the infant’s abdomen.

- Setting and Control

① Air mode: The measured value is displayed on air temperature region in upper left

of screen and the setting value is dis played on setting region in upper right of screen

with blue.

1) To unlock the key, push t he [keylock] key. (red underline on s etting value)

2) Push the [up key]

or rotate CW the knob to raise the setting temperature from

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23.0˚ to 37.0˚ in 0.1˚ increments. In t emperature override mode, push the [up key] or rotate CW the knob to raise the setting temperature from 37.1˚ to 39.0˚.

Push the [down key]

or rotate CCW the knob to lower the setting temperature from 39.0˚ to 23.0˚ in 0.1˚ increments. .

3) To confir m t he setting va l ue and lock the key, push the [keylock] key.

4) According to this value, the temperature of inside of the hood is controlled

automatically.

Figure 4-8. Measurement and Control of Temperature (Air mode)

Note: When key locking is released, LED is off and key lock icon is removed. Also, if no

keys are pushed or knob is rotated within 10s of selecting display, it is automatica lly locked.

② Skin mode: The measured value i s displayed on skin temperature region in upper

middle of screen and the setting value is displayed on setting r egion in upper right of screen with yellow.

1) To unlock the ke y, push the [keylock] key. (red underline on setting value) By

pushing [air/skin]

2) P us h the [up key]

35.0˚ to 37.5˚ in 0.1˚ increments. In temperature override mode, push the [up key]

or rotate CW the knob to raise the setting temperature from 37.6˚ to 39.0˚.

Push the [down key] from 39.0˚ to 35.0˚ in 0.1˚ increments.

3) To confirm the setting value and lock the key, push the [keylock] key.

4) To maintain the infant’s body temperature, the temperature of inside of the hood is

controlled automatically.

5) When using two skin temperature sensors, it is displayed as below figure 4-9. In

order to use skin mode as the control mode, skin temperature 2 should be removed.

key, change control mode status.

or rotate CW the knob to raise the setti ng temperature from

or rotate CCW the knob to lower the setting temperature

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WARNING

Premature neonates below 30 weeks may need humidity over 80% for

out water vapor on the wall because of possible bacterial colonization.

Figure 4-9. Measurement and Control of Temperature (Sk in mode)

4.6 Humidity Measurement and Control

Measurement:

Humidity measurement starts at the same time when BT-500 is powered on.

- Setting and Control

The measured value is displayed o n humidity region in upper middle of screen and the setting value is displayed on setting region in upper right of sc reen with sky-blue.

1) To unlock the ke y, push the [keylock] key. (red underline on setting value) By

pushing [parameter]

2) P us h the [up key]

setting humidity from 40% to 95% in 1%p increments.

3) P us h the [Enter]

button for lock.

4) According to this value, the re la tive humidity of inside of the hood is controlled

automatically.

Figure 4-10. Measurement and Control of Humidity



long periods of time. In this high humidity environment, water vapor condensation could build up inside hood surface and prolonged condensation can lead to rain-out or watery surface underneath mattress. It is highly recommended that user should prevent water vapor condensation by controlling temperature and humidity and clean

key, cha nge the parameter.

or [down key] or rotate the knob to raise or lower the

button for reflecting set -up and push the [keylock]

4.7 O2 Measurement and Control

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WARNING

Oxygen flow rate cannot guarantee the accurac y of oxygen

- Measurement: O2 concentration in the hood begins automatically starting operation

at the same time. The measured value is displa yed on O2 region in the lower of screen with green.

Setting and Control: The measured value is displayed on O2 region in the lower of screen; setting va l ue i s d isp layed on set ti ng r e gio n i n up p er righ t o f sc re e n wit h gr ee n.

Figure 4-11. O2 Measurement

1) To unlock the ke y, push the [keylock] button. (red underl i ne on setting value) B y

pushing [parameter]

2) To unlock the key, push the [ keylock]

3) To change the setting mode, push the [parameter]

Temperature, Humidity, Oxygen sequentially.

4) To set the key, push the [up key]

key to set the O2 concentratio n u nit 1 %

5) Press the [Enter]

button to reflect the setting and then press the [keylock]

button to lock.

6) Adjust the O2 concentration in accordance with the s etting value automatically.

Figure 4-12. O2 Measurement and Control



concentrati on in the inc ubator.

 Oxygen concentratio n should be continuously measured by calibrate d

oxygen analyzer.

 Administration of oxygen may increase the noise level for the infant

within the infant incuba tor.

 An oxygen analyzer shall be used separately when oxygen is delivered

to the infant.

 Use of anesthetic agents can interfere with oxygen analyzer accuracy.  As oxygen use increases the danger or fire, do not place auxiliary

equipment that produces sparks in an incubator. Pe rsonal injury or

key, cha nge the parameter.

button. (red underline on setting value)

button. Setting mode is

, [down key] button or control Knob

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equipment damage could occur.

 Disconnect the incubator from the hospital oxygen source when oxyge n

is not in use. Failure to do so could result in personal injury or equipment damage.

4.8 Weighting Scale Measurement

- Measurement: Weighting measurement star ts at the same time when BT-500 is

powered on. Measured data continuously displayed on lower part of screen in white Kg or pound unit according to set record.

Figure 4-13. Measurement of Weighting Scale

4.9 SpO2 and PR(pulse rate) Measuremen t

- Measurement: To measure SpO2, apply the probe to the patient’s toe or earlobe. The exact applied part is decided according to the medical opinion. The measured value is displayed o n SpO2 region in lower of screen in white(SpO2) and blue(PR)..

4.10 Menu functions

Functions of system, alarm, trend, and modules are able to b e set and changed by using Menu options. After pushing the [keylock] key to unlock, press the [menu] key to go to the menu function.

Figure 4-14. Measurement of SpO2 and PR

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Figure 4-15. Menu Functions

To change and move to other category, use Control Knob. CW or CCW rotation of the Knob is used to shift between menu options and pushing is used to reflect the setting value. When the cursor is located on arrow, you can move to other menu category tabs.

① System: You can change Temperature unit, Weight unit, Language, Time a nd

Warm-up mode. There are 3 different kind of warm-up mode Silent, Normal, and Fast Mode.

- Silent: Warm-up time will take 1 hour around with noise level less than 45dB.

- Normal: Warm-up time will take 45Min around with noise level less than 55dB.

- Fast: Warm-up time will take 25Min. around with noise level more than 66dB.

② Alarm: The silence period of alarm can be set to 5, 10, 20 30, and 60 minutes. For

the silence period, alarm sound is silent and silent time is displayed on main operation display shown as below. SpO2 Alarm delay refers to the delay time after an alarm condition occurs, an alarm sounds until the occurrence. You can set the delay time 0,5,10 and 15 seconds. And you can set PR Beep volume level. There are 5 different volume levels.

Figure 4-16. System Item

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Figure 4-17. Alarm Item and silence period

③ Trend: Trend period is set as 9, 18, 36, and 72 hours and it is displayed on main

operation display. Also each trend displa y data are possible to enable or disable: air temperature, skin temperature, humidity and ox ygen. T hese trend displa y datum are displayed on main operation display with setting period.

Figure 4-18 (a). Trend Item

④ Modules : The calibration of O2(21%, 100%, weight is available. Select the O2

setting mode or measured mode of main display. And select the Cam mode, Graph mode, Masimo mode of external monitor in the monitor mode function. Read the chapter 4.11 to understand explanation of each monitor mode. In addition, set the Cam. Hor. Mirror to reverse the display from side to side.

Figure 4-19 (b). Trend on Main Operation Display

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This mode is provides the best combination of

mode is recommended for the majority of patients.

This mode should be used for the sickest patients,

and patient contact is continuous.

This mode is t he least sensitive in pic king up a reading

becoming detached. (Pediatric, combative, etc. )

This mode is always on for 2-4 and 4-6 averaging modes.

4 seconds

8 seconds

10 seconds

12 seconds

14 seconds

16 seconds

SpO2

alarm limit

If the SpO2 value is lower than this value, an alarm is occurring.

If the PR value is higher than this value, an alarm is occurring.

If the PR value is lower than this value, an alarm is occurring.

Figure 4-20 Module Menu

⑤ SpO2 : Below table is the description if SpO2 setting menu. Please refer to below

table to set SpO2 settings. Changed setting will be apply on SpO2 and display on external monitor, please refer to 4.11 for external monitor explanations.

Items Description

Normal

sensitivity

sensitivity and probe-off detection performance. This

where obtaining a reading is most difficult. Maximum

Algorithm

mode

Maximum sensitivity

Sensitivity is designed to interp r e t a nd display data for even the weakest of signals. This mode i s recommended during procedures and when clinician

on patients with low perfusion but has the best

APOD

detection for prove-off conditions. This mode is useful for patients that are at particular risk of the sensor

FastSat

OFF -

2 seconds

SpO2

SpO2 avera ging time

averaging

Low

PR Alarm

limit

High

Low

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Figure 4-21. SpO2 Item

⑥ Help : BT-500 provide the simple information about the equi pment. The

information is as follow:

- parts of full set BT-500

- main control panel and main display

- how to use and change mode and parameters

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Figure 4-22. Help Item

⑦ Scale : If weighing scale module is connected, a menu of weight calibration appears.

Press the [keylock] more than 2 seconds then, the menu will be displayed.

button to unlock and press the [Menu key] button

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WARNING

4.11 Pulse Oximeter

• Pulse oximeter of BT-500 must be operated by qualified personnel only.

Pulse oximetry is a cont inuous and non-invasi ve method of measuring the level of arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the finger tip fo r adult s, and the ha nd or fo ot for neonate s. T he sensor is conne cted to the pulse oximetry instrument with a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data in two ways: 1) as a percent value for arterial oxygen saturation (SpO2), and, 2) as a pulse rate (PR).

- Operating Principles

: The BT -500 MS board pulse oximeter is based on three principles:

1. Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophoto metry).

2. The volume of arterial blood in tissue and the light absorbed by the blood changes during the pulse (plethys mography).

3. Arterio-venous shunting is highly variables and that fluctuating absorbance by venous blood is a major component of noise during the pulse.

The pulse oximeter of BT-500 as well as traditional pulse oximetry determines SpO2 by passing red and infra red light into a cap illary b ed and mea suring cha nges in li ght absorption during the pulsatile cycle. Re d and infrared lig ht-emitting diodes (LEDs) i n oximetr y senso rs serve as the light sources, a photodiode serves as the photodetector. Traditional pulse oximetry assumes that all pulsations in the light absorbance signal are caused by oscillations in the arterial blo od volume. This assumes that the blood flow in the region of the sensor passes entirely through the capillary bed rather than through any arteriovenous shunts. The traditional pulse oximeter calculates the ratio of pulsatile absorbance (AC) to the mean absorbance(DC) at each of two wavelengt hs, 660 nm and 905 nm: S(660) = AC(660) / DC(660) S(905) = AC(905) / DC(905) The oximeter then calculates the ratio of these two arterial pulse-added absorbance signals: R = S(660) / S(905) This value of R is used to find the saturatio n SpO software. The values in the look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia studies. The Masimo SET MS board pulse oximeter assumes that arterio-venous shunting is h ighly

in a look-up table built into the oximeter ’s

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variable and that fluctuating absorbance by venous blood is the major components of noise during the pulse. MS board decomposes S(660) and S(905) into an arterial sig nal plus a noise component and calculates the ratio of the arterial signals without the noise: S(660) = S1 + N1 S(905) = S2 + N2 R = S1 / S2 Again, R is the ratio of two arterial pulse-added absorbance signals and its value is used to find the sat uration SpO values in the empirically derived equation are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteer s in induced hypoxia studies. The above equations are combined and a noise reference (N’) is determined: N’ = S(660) – S(905) x R If there is no noise N’ = 0: then S(660) = S(905) x R which is the same relations hip for the traditional pulse oximeter. The equatio n for the noise reference is based on the value of R, the value being seeked to determine the SpO corresponds to SpO there R-values. The S(660) and S(905) signals are processed with each possible N’ noise reference through and adaptive correlation canceler(ACC) which yields an output power for each possible value of R(i.e., each possible SpO Saturation Transform (DST™) plot of relative output power versus possible SpO shown in the following figure where R corresponds to SpO

in an empirically derived equation into the oximeter’s software. The

. The MS board software sweeps through possible values of R that

values between 1% and 100% and generates an N’ value for each of

from 1% to 100%). The result is a Discrete

value as

= 97%:

The DST plot has two peaks: the peak corresponding to the higher saturation is selected as the

value. This entire sequence is repeated o nce every two seconds on the most recent four

SpO

seconds of raw data. The MS board SpO arterial hemoglobin saturation that is updated every two seconds.

therefore corresponds to a running average of

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WARNING

Do not remove the grounding conductor from the power plug on any

plug must be intact and undamaged.

WARNING

Do not place the monitor or external power supply in any position that

- Grounding

Connect the oximeter only to a three-wire, grounded, hospital-grade receptacle. The threeconductor plug must be inserted into a properly wired three-wire receptacle; if a three-wire receptacle is no available, a qualified electrician must install one in accordance with the governing electrical code.



circumstances.

 Do not use extension cords or adapters of any type. The power cord and

If there is any doubt about t he integrity of the protective earth conductor arrangement, operate the oximeter on internal battery power until the AC power supply protective conductor is fully functio nal .

- Patient Isolation

To ensure patient electrical isolation, connect only to other equipment with electronically isolated circuits.

Note: Do not connect to an electrical outlet controlled by a wall switch or dimmer.

- Cabling entanglement/strangulation

As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.



might cause it to fall on the patient. Do not lift the monitor by the power supply cord or patient cable; use only the handle on the mo nitor

- RS-232 & Alarms

RS-232 System Interconnection. Consult IEC-601-1-1 for system inter connection guidanc e. The specific requirements for system interconnection are dependent upon the device connected to the MS board pulse oximeter and the relative locations of each device from the patient, and the relative location of the connected device to the medically used room containing the MS board pulse oximeter. In all circumstance the MS board pulse oximeter must be connected to a grounded AC power supply. T he MS board pulse oximeter is referred to as an IEC 60601/F de vice in the summary of situations table contained in IEC 60601-1-1.

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Check alarm limits each time the MS board pulse oximete r is used to ensure that they are appropriate for the patient being monitored.

4.12 External Monitor

BT-500 uses external 7” Color TFT LCD monitor that displays measured values from the control and video of infant inside the hood. Cam mode, Graph mode and Massimo mode are shown as bel ow

(1) Cam Mode: Air temperature, skin temperature, humidity, oxygen concentration and weighting scale are displayed on external monitor with real-time video of infant.

Figure 4-23. External Monitor Display

There’s no information for the Masimo board. If there’s some alarms, it would display message “Check alarm on Masimo mode”.

(2) Graph Mode: Air temperature, skin temperature, humidity, oxygen concentration and weighting scale, SpO2 and PR are displayed on external monitor with real-time video of infant. Also, graphs of each parameters are displayed.

Figure 4-24. External Monitor Display (b) Graph Mode

There’s no information for the Masimo board. It just display basic parameter ( SpO2, PR, Plethysmograph, and SIQ ). If there’s some alarms, it would display message “Check alarm on Masimo mode”.

(a) Cam Mode

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(3) Masimo Mode: Air temperature, skin temperature, humidity, oxygen concentration and weighting scale are basically displayed. SpO2 and PR are mainly displayed.

Figure 4-25. External Monitor Display

- Parameter Region

- Information Region

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RED

YELLOW

RED

- PPG and SIQ Region

- Alarm messages on Alarm Region

Messages display Messages display

- Board failure & Diagnostic Failure code Region

Display when the event occurred. If no failure, it would be blanked. Each description about

error codes is explained in Section 8.

4.13 Shut down

To ensure safe terminating operation of BT-500, follow as below.

1) Turn off the Power switch to power down the incubator.

2) Turn off the main power source.

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4.14 Calibration of O2 module

Follow the direction to set and co ntrol O2 concentration for improving accuracy in the hood

of BT-500.

Calibration of O2 concentration 21 % : Calibrate O2 concentration to atmospheric oxygen

concentration as the standard.

1) Move the position of the sensor module to O2 calibration position. At this time,

alarm can be occurred. But if sensor module relocates normal position after calibration, it operates normally.

2) To unlock the key, push the [keylo ck]

3) Press the [Menu]

category in [modules] category.

4) Handle the knob to select the 21 % Calibration category. Push the knob to compete

the calibration.

5) If it is indicated as “Done” massage, calibration completes the work.

Otherwise, it is indicated as “Fail” massage, check the O2 sensor and atmospheric oxygen whether normal concentration.

6) Move the sensor module to normal position.

Calibration of O2 concentration 100 % : Calibrate O2 concentration to 100 %. Calibra tion of O2 concentration 100 % should be performed after Calibration of O2 concentration 21% is completed.

1) Move the position of the sensor module to O2 calibration position. Sensor module

and “O2 calibration kit” plac e tight. At this time, alarm can be occurred. But if sensor module relocates normal p osition after calibration, it operate s nor mally.

2) Connect “O2 calibration kit”to be injected 100% O2 concentration. Set oxygen flow

to 0 PLM. Pressure of O2 is between 40PSI(275kPa) and 50PIS(344kPa)

3) Turn "Sealing va lve" clockwise to close contact with the sensor module and the "O2

Calibration Kit".

4) Be careful not to obstruct the "O2 calibration kit" of ”O2 outlet”

5) Inject oxygen into “O2 calibration kit” At this time, the flow rate set between 5

LPM and 7 LPM (Litter Per Minute). I nject oxygen from 5 minute to 6minute to recognize O2 sensor fully.

button to enter the menu category. Select the O2 Calibration

button. (red underline on setting value)

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6) To unlock the key, push the [keylo ck] button. (red underline on se t ting value)

7) Press the [Menu]

button to enter the menu category. Select the O2 Calibration

category in [modules] category.

8) Handle the knob to select the 21 % Calibration menu. Push the knob to compete the

calibration.

9) If it is indicated as “Done” massage, calibration completes the work.

Otherwise, it is indicated as “Fail” massage, check the O2 sensor and atmospheric oxygen whether normal concentration.

10) Move the sensor module to normal position.

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System alarms

Section 5

Alarms

Alarm of BT-500 indicates the failure condition of equipment. According to each alarm condition, alarm messages are displayed on the fro nt LCD. At the sa me time, alarm sound is caused and sensor module’s LED blinks. Also all setting values for alar m condition do not changed by any interrupt such as power on and off.

Followings are types of alarm message. Alarm pop-up window is activated in the center as below in case of the alarm situation.

5.1 System alarms

This alarm is activated when disorder is occurred during operation of equipment. It is possible there will be a delay of 1 second to determine and check an accurate alarm

condition.

Figure 5-1 activation of pop-up window

Messages display Sound

O O O Problem wit h main motor

O O O Problem with main heater

LED flash

Descriptions

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Situation o f pressing the

minute

Problem with air humidity

hood

Problem with air

sensor in the hood

Required to remove the skin

skin mode control.

O O O Problem with water heater

O O O

key button more than 1

measurement sensor in the

temperature measurement

Problem with power of impeller motor

Problem with no t wor ki ng or malfunct ion of impeller

Problem with sk in temperature probe

temperature sensor 2 during

When the se ns or module is disconnected

Sensor module is not placed in the proper position.

Table 5-1. System alarm message

When Hood doors are open or close, BT-500 shows the condition through icons instead of alarm sound.

5.2 Temperature alarms

This alarm is activated when either disorder is occurred measuring air temperature in the hood or body temperature and difference of constant figure and over in setting temperature value.

Door open/close icon

Front and rear doors are open.

Front and rear doors are close open

Front door is open.

Rear door is open.

Table 5-2. Door Open /Close Icon

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Temperature alarms

LED flash

If the temperature measured

temperature over 2.5 ℃

If the measured temperature

temperature over 1.5 ℃

If the temperature measured

temperature over 2.5 ℃

In case the measured

temperature is over 37 ℃.

In case the measured

temperature is over 37 ℃.

In case the measured

is over 37 ℃.

Messages display Sound

O O O

Descriptions

is lower than the set

is higher than the set

is lower than the set

If the measured temperature is higher than the set temperature over 1.5 ℃

①

temperature reaches more than 38

℃ when the s etting

temperature is under 37 ℃.

② In case the measured temperature reaches more than 39 ℃

when the s etting

①

temperature reaches more than 38

℃ when the s etting

temperature is under 37 ℃.

② In case the measured temperature reaches more than 39 ℃

when the s etting

①

temperature reaches 37.5 ℃ ±0.5 ℃ when the setting temperature is under 37 ℃.

O O O

② In case the measured temperature reaches more than 39.5 ℃ ±0.5 ℃ when the set t ing temperature

Table 5-3. Temperature alarm message

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Humidity alarms

LED flash

There is no water in the internal water tank.

Oxygen alarms

LED flash

If the measured values of the

concentration

concentration over 5 %

Measured O2 concentration is

concentration over 5 %

LED flash

Weigh in exce ss o f 10kg i s on the mattress.

5.3 Humidity alarms

This alarm is activated when humidity in the ho od is lo wer than s ett ing value o r the re i s no water in the tank.

Messages display Sound

O O O

Measured value is lower than setting value over 5%p.

Descriptions

Table 5-4. Humidity alarm message

5.4 Oxygen alarm

The alarm will be activated when there are differences between setting O2 concentration range and O2 concentration inside of hood. It may be activated when there is malfunction on O2 control module.

Messages display Sound

O O O

In case there is probl em with power of O2 control module.

If O2 Control module is disconnected

two O2 Sensor is a difference more than a certain

Descriptions

5.5 Weighting Scale alarms

This alarm is activated when the measured weight is not in the measurable range which means an object other than infant is placed on the mattress.

Weighting Scale alarms

O O O

Table 5-5. Oxygen alarm message

Messages display Sound

O X X

Table 5-6. Weighting alarm message

Measured O2 concentration is lower than setting O2

higher than setting O2

Descriptions

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WARNING

Do not place the monitor or external power supply in any position that

properly before being used again.

5.6 Alarm self-test

The self-testing is necessary for the alarm system to check whether the performance of the audible and visible alarms has degraded over time.

- System alarm

After removing the sensor module from the top of hood, check the followings. The

message is displayed on LCD with the audible alarm. Also, the red LED flashes on the sensor moduel connector.

- Power fail alarm If the power cable is disconnected with power on, the LCD screen turns off and the red LED flashes with a continuous audible alarm.

Note: A fully charged battery should supply the power failure alarm for approximately 30

minutes. If the alarm is tested for the full 10 minutes, B T-500 must be run at least 3 hours to recharge the battery before it is used to the patient. Total recharge time is 5 hours when t he main power switch is o n.



might cause it to fall on the patient. Do not lift the monitor by the power supply cord or patient cable; use only the handle on the monitor

 Do conduct Alarm self-test whether the alarm function is working

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WARNING

Do not immer s e the sensor in water, solvent s , or cleanin g s olutions.

patient.

Cleaning & Maintenance

This chapter contains instructions for the care and cleaning of the BT-500 unit and i ts accessories.

The BT-500 requires proper ca re and preve nt ive maintenance. This ensures consistent operation and maintains the high level of performance necessary.

6.1 General cleaning method and precautions

(1) Cleaning Methods

- Yo u ca n maint ai n t he c le anliness using va r io us met hod s. T hou gh, to avo i d t he d a mages or contamination, use the following recommende d methods. .

- Clean up with warm water and detergent.

- Clean completely the incubator after each baby is discharged and before being used again.

- If you use the materials (unauthorized materials) that can cause damage to the device, it is impossible to get free repair service although the device is in warranty period.

- Do not use steam cleani ng the all parts of incubator. The excessive moisture can cause damage.

- Please maintain cables with no dust and soil. And clean cables with wet fabric (water temperature is about 40˚C / 104℉). Please clean cables using clinical alcohol once in a week.

- Do not immerse the device or sensor in liquid or a cleanser. Also all liquid must not be permitted to enter in the device or sensor.

- When cleaning the surface of the air circulation well, take care to prevent liquids from entering the motor. Then, dry with a clean cloth or paper towel.

- When you clean the sensor module, inner and outer wall of the hood, do not use alcohol that can cause crazing (small stress crack) of the clear acrylic.



Do not sterilize by irradiation, steam, or ethylene oxide.

 Do not immerse the patient cable in water, solvents, or cleaning

solutions (the patient cable connector s sterilize by irradiation, steam, or ethylene oxide.

 Incubato r should be thoroughly cleaned and disinfected after each

baby is discharged and before being used again. If patient is cared for in an incubator for more than 7 days wit ho ut the wit ho ut the device being cleaned or disinfected, it may cause an infection of

Section 6

are not water proof). Do not

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WARNING

Turn off the BT-500 and unplug the BT-500 from the AC power

clear acrylic hood.

WARNING

Turn off the BT-500 and unplug the BT-500 from the AC power

Check the temperature of the radiator before cleaning.

CAUTION

Take extra care when cleaning the display surfaces, which are

soft, dry cloth.

WARNING

Do not remove and clean the humidity module in operation.

specifically identified in this chap te r.

(2) Maintenance Methods

- Once a month, rub the main body and accessories using soft fabric with alcohol. Do not use thinner, lacquer, ethylene or oxidant.

- After using the device, please store the device where the place has -20˚C~+60˚C of temperature and 0%~95% of humidity.

- Restrict the device be used by doctors and nurses only.

6.2. Hood

Keep the external surface clean and free of dust, dirt, and residual liquids. Clean with a

damp cloth using mild soap and water or hospital approved, nonabrasive disinfectants.



source and detach all accessories before cleaning. Do not immerse the unit in water or allow liquids to enter the case.

 Do not use alcohol for cleaning. Alcohol can cause crazing of the

6.3. Shell, Sensor module, Scale module, Basket

Keep the external surface clean and free of dust, dirt, and residual liquids. Clean with a

damp cloth using mild soap and water or hospital approved, nonabrasive disinfectants.



source. Do not immerse the unit in water or allow liquids to enter the case.

 Be careful not to have a burn when clean the radiator of shell.



sensitive to rough hand ling. Rub the lens that covers them with a

6.4 Water tank

Maintain inside o f the water tank clean from the dust, the residue, t he remaining liquid. Use the mild soap, water, non-abrasive sanitizer approved in the hospital and wipe with damp cloth. Also, the water tank can be disinfected by using autoclave.

  The humidifier reservoir (water tank) should be cleaned and the

water changed every day.

 Do not autoclave the components of device, except for water tank

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WARNING

All Masimo sensors and accessories listed to be available for

6.5. Skin temperature sensors and Sp O2 sen sors.

Keep the external surface clean and free of dust, dirt, and residual liquids. Clean with a

damp cloth using mild soap and water or hospital approved, nonabrasive disinfectant s



device.

6.6 Drain of residual water

The residual water in the humidity module can cause bacteria multiplication or equipment damage when it is fro ze n. When the infant leave the hospital or the equipme nt not being used, remove the residual water in the humidity module as follows:

1) To cool down the humidity module, turn off the BT-500 and remove water tank and

wait about 60 minutes.

2) Remove the bas ket from the bo ttom side as shown in the figure . Place the water tank

more than 1L capacity below the drain valve.

3) Remove the dr ain valve from shell bottom using spanner.

4) Waiting until no more wat er has fall down from the drain and tur n on the BT-500.

5) Press down the [parameter Key] more than 5 seconds and the following

will be displayed. Enter [0,0,1,1] to start the heater operated to remove the moisture from humidity module. For drying out the humidity module, the heater will be operating about 4minutes and 40 seconds. Be careful the heated vapor can be expelled at the drain valve.

6) The BT-500 will be reset. Turn the power off and assemble the drain valve as reverse

order.

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WARNING

The humidity module can be sufficiently hot to cause burns.

WARNING

The operation of each part should be checked every time before the

  The hot water can be poured from drain valve.

6.7 Regular Inspection

Similar to most medical equipmen t, BT-500 has t o be inspected periodically on an annual basis in general. Refer to the service manual which is supported by Bistos Co.,Ltd. about inspectional items.

Regular inspection must be performed by the company’s technician. The user and operator must not disjoint or remodel the device.



device is used to patient.

 The operation of each function should be checked every thre e-

month in general.

 If any defect should be detected in an inspection, indicate on the

unit that it is out of order, stop using it immediately, and contact our distributor in local area.

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CAUTION

The internal battery must be handled by the company’s technician

could be hazardous to human health and the environment. DO NOT

authorities for more information. This product may be returnable to your

6.8 Battery Replacement and Disposal

If a loss of battery operation run time is noticed, the battery could possibly require replacement. When disposing or replacing of internal Li-ion battery, adhere to all applicable laws regarding recycling. Avoid storing battery above 140°F. If c lothing or s kin comes in contact with material from inside the battery, immediately wash with plenty of clean water.



only. Do not attempt to open the BT-500.

The internal battery is consumables. Therefore the operation time by the battery can be decreased. If the operation time is not long enough, please contact service center and change the battery. If this system is used with not sufficient operating time by the internal battery, it is possible to be shut down the system because of the lack of the internal battery’s capacity. This situation can cause not intended stop of measuring and monitoring function.

6.9 Disposal of the BT-500

When dispos ing of the BT-500, adhere to all applicable laws regarding recycling. If you are not able to dispose the BT-500 or you need a help for disposing the BT-500, please contact us. In the case of there are no appropriate ways to dispose, we will pick up the BT-500 for you.

DISPOSAL

In order to comply with EU Direc tive 2002 /96/EC on Waste Electrical and Electronic Equipment (WEEE) : This product may contain material whic h

DISPOSE of this product as unsorted municipal waste. This product needs to be RECYCLED in accordance with local regulations, contact your local

distributor for recycling - conta c t the d istr ibutor for details.

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Section 7

Specifications

BT-500 Infant Incubator Specifications:

* W : Width, D : Depth, H : H e ight

Physical Characteristic s

(Basic form) Dimensions – 1024mm (W) x 690 mm(D) x 1354mm (H) Weight – approx. 99.3kg

(Fully-loaded) : IV-Pole, IV-Plate, Plate, E xter nal L CD monitor, Shelf, Weighing scale, CCD Camera, Lifting stand , O2 Contr ol Module , Check valve) Dimensions – 1441mm (W) x 797 mm(D) x 1500mm (H) Weight – approx. 117.5kg Weight with safe working load – approx. 156.5kg

Body (Shell + Hood)

Dimensions – 1024mm (W) x 604 mm(D) x 773mm (H) Weight – approx. 52.7kg

Stand

- FIXED STAND Dimensions – 1009.5mm (W) x 815 mm(D) x 645mm (H) Weight – approx. 36kg

- LIFTING STAND Dimensions – 1009.5mm (W) x 815 mm(D) x 651mm ~ 851mm (H; MIN ~ MAX) Weight – approx. 40.5kg

Accessories

- IV PLATE Dimensions – 479mm (W) x 402 mm(D) x 756.4mm (H) Weight Limit– approx. 5kg

- PLATE Dimensions – 402mm(W) x 302mm(D) Weight Limit – approx. 11kg

- IV POLE Dimensions – 300mm (W) x 310 mm(D) x 718mm ~ 1068mm (H; MIN ~ MAX) Weight – approx. 2.5kg

- External 7” Color TFT LCD Dimensions – 364.7mm (W) x 35mm(D) x 839mm (H) Weight – approx. 3kg

Tilt angle – +30˚, -50˚ / Swivel angle – +180

˚, -140˚

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- SHELF Dimensions – 219mm (W) x 334mm(D) x 36mm (H) Weight – approx. 2.7kg Weight Limit – approx. 3kg

- BASKET Dimensions – 464.2mm (W) x 490.5mm(D) x 241.3mm (H) Weight – approx. 4.3kg Weight Limit – approx. 10kg

- BASKET PARTITION Dimensions – 391mm (W) x 205mm(D) x 53mm (H) Weight – approx. 0.45kg

- WEIGHT SCALE Dimensions – 810mm (W) x 400mm(D) x 46.6mm (H) Weight – approx. 5.8kg Measurement – 0~10kgf, ±50g

- CCD CAMERA (NTSC or PAL) Dimensions – 69.1mm (W) x 46mm(D) x 38mm (H) Weight – approx. 40g Resolution – 510 x 492 Pixel

- SENSOR MODULE Dimensions – 157mm (W) x 119.2mm(D) x 64.5mm (H) Weight – approx. 270g

- SENSOR MODULE & CCD CAMERA ASS’Y Dimensions – 194mm (W) x 119.2mm(D) x 81mm (H) Weight – approx. 310g

- SpO2 Probe Wire lengt h – 1000mm Weight – approx. 30g

- SpO2 Probe Extension Weight – approx. 30g Wire lengt h – 3080mm

- MATTRESS Dimensions – 727mm (W) x 377mm(D) x 27mm (H) Weight – approx. 30g Tilt angle – ±12°

-O2 Control Module Dimensions – 300mm (W) x 170mm(D) x 180mm (H) Weight – approx. 760g

-Check valve Dimensions – 330mm (W) x 365mm(D) x 65mm (H) Weight – approx. 460g

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External:

Power Adaptor

Total Power Rating : 100-240 Va c 50/60Hz 1200 VA

Internal:

Li-ion, rechargeable battery(3.6Vdc 1 cell. 2500mAh) Alarm sounds for 30 minutes while no power.

Operating Temperature:

20°C to 30°C (68°F to 86°F)

Operating Humidity

0% to 95%, non-condensing

Storage/Transport Temperature:

–20°C to 60°C (–4°F to 140°F )

Storage/Transport Humidity:

0% to 95%, non-condensing

Pressure Altitude

70kPa – 106kPa 0 - 2000m (0 -6,561.68 ft)

Maximum Carbon Dioxide(CO2) concentration

< 0.5% at a point 15cm above from the center of the mattress

Air Velocity over the mattress

< 0.3m/s

Warm-up time

Normal mode : 45 minutes, <55dBA

Fast mode : 30 minutes, <66dBA

Sound pressure level

Under 45dBA in environmental sound pressure level :

40 dBA

Parameters

Value

Control range

Normal mode : 23.0 ℃ ~ 37.0 ℃ Measurement range

20.0 ℃ ~ 45.0 ℃

Accuracy

± 0.5 ℃

Parameters

Value

Control range

Normal mode : 35.0 ℃ ~ 37.5 ℃ Measurement range

25.0 ℃ ~ 45.0

Accuracy : ± 0.5 ℃

Accuracy of skin temperature sensor

± 0.3 ℃

Safety

Complies with EN60601-1, EN60601-1-2, EN60601-2-19 Class I Equi pment & Internal Powered Equipment Continuous Operation Type BF applied parts Skin temperature Probe : IPX1 / SpO2 Probe : IPX2 / Foot Switch : IPX6

Power

5 hours to full recharge when main power switch is on.

Environmental

in hood

Silent mode : 60 minutes, <45dBA

≤

Performance

Air Temperature : Control and measurement o f air temperature in the hood

Override mode : 37.1 ℃ ~ 39.0 ℃

Skin Temperature : Control and measurement of skin te mpe rature of the infant

Override mode : 37.6 ℃ ~ 39. 0 ℃

℃,

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Parameters

Value

Control system

Steam humidifier

Control range

40 % RH ~ 95 % RH

Measurement range

15 % RH ~ 99 % RH

Accuracy

± 5 %p

Parameters

Value

Measurement range

18 % ~ 100 %

Accuracy

± 5 %p

Parameters

Value

Control range

21 % ~ 65 %

Accuracy

± 5 %p

Max inlet pressure

120 PSI

Hose diameter

8mm, 9.5mm, 11mm, 13mm (Use only oxygen hose )

Parameters

Value

Measurement range

0.000 ~ 10.000 kg

Accuracy

± 50 g

Parameters

Value

Measurement range

no operating : 25 ~ 240 bpm Error tolerance

3 digit

Resolution

1 bpm

Parameters

Value

Measurement range

1% ~ 100%

Accuracy

With no motion : 70% ~ 100 % , ± 3 digit

0%~ 69 % , unspecified

Resolution

1 %

Humidity: Control and measure ment of relative humidity in the hood

Water box: Autoclavable

O2: Measurement of O2 in the hood

O2: Servo control of O2 in the hood

Weighing Scale: Me asurement of weighing scale of the infant

Pulse Rate(PR) : Measurement of pulse rate of the infa nt

operating : 25 ~ 240 bpm

SpO2: Measurement of SpO2 of the infant

0%~ 69 % , unspecified

With motion: 70% ~ 100 % , ± 3 digit

Alarm Signal Sound pressure Priority Measured sound pressure level A-weighted background level

High(All) 73dBA 48dBA

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Main heater overheated caused

malfunction

Check the fus e F1 of BD-500-MAIN.

If not, replace the humidity module.

Check the fus e F1 of BD-500-MAIN.

If not, replace the humidity module.

Section 8

Troubleshooting

8.1 General Checking

When the following problems are happened, before contact the head office, please check following measures.

1. When you can’t power on the device.

- Please check that an adaptor of the device is connected to the AC connector properly.

- Please check the LED in the front panel is green or yellow.

2. When values are not displayed

- Please check that sensor and extension cables are properly connected to sensor connector.

- Please check that sensor works properly after connect cables.

3. When values are not in proper range

- Please check if the hood is closed well.

- Please check the probe is attached properly.

- When setting the scale to zero or measuring weight, please check if any object is placed

on the measuring plate.

If the unit has trouble, check the possible cause in sequence from above.

8.2. Alarm Message Checking

If the BT-500 has some problem for operation, it display alarm messages as below.

- Alarm messages on Main Display

Alarm Messages Cause Solution

Motor Failed Motor driver malfunction

Overburned

Heater

Humidity Heater

failed

Heater system

failed

Stuck key Key or knob is stuck.

by the broken impeller of Main fan motor or thermostat

Water heater of humidity

module malfu nct ion

Main heater of shell malfunction

Replace the main board (BD-500MAIN)

Stop the operation of BT-500 and

contact to the distributor or BISTOS.

If the fuse F1 is broken, replace it.

Check key a nd knob if the y are stuck. Replace U3 of BD-500-CPU CTRL.

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In Skin mode, Skin senso r probe

connector. .

e to comprehend the

Air sensors

failure

Sensor mod

disconnected

Sensor module

not in position

Skin Probe Disconnect

Fan power failure Fan power system malfunc tion

Air temperature sensor malfunction

Replace CIR-500-sensor sub or CIR500-sensor

Disconnected the sensor module Connect the sensor module to shell.

Sensor module not in position on hood

is disconnected from

Check the position of the s ensor module.

Connect the skin sensor probe, or change the control mode to air mode.

Replace the main board (BD-500MAIN)

- Alarm messages on Alarm Region of External Monitor

Alarm Messages Solution

Bad Sensor ID offset Open LEDs Short detector Interference detected Shorted LEDs No adhesive sensor No cable No sensor connected Sensor off patient Too much ambient light Unrecognized sensor Low SpO2 High pulse rate Low pulse rate

Check the sensor status. If you are not abl causes, connect the service personnel.

Check the patient status.

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- Error codes of External Monitor

If the external monitor displays alarm error codes such as board failure codes and diagnostic failure codes as below. For this, connect the service personnel immediately.

Board Failure Codes Meaning

32 DSP: Checksum failure 33 DSP: Program memory test failure 34 DSP: Data Memory test failure 35 DSP: Detector ADC Interrupt Test Failure 36 DSP: MCU Interrupt failure 37 DSP : Diag queue Overrun 38 DSP : Hardware Status Failure 39 DSP : Raw Queue Overrun 40 DSP: MCU Watch Dog Failure

Diagnostic failure Code Meaning

0001 LED Ground 0002 Reference Voltage 0004 Digital Voltage 0008 DSP Voltage 0010 Positive LED V oltage 0020 Red current level 0040 IR Current level 0080 Digital ground 0100 Positive Preamp voltage 0200 Preamp 0400 Positive Detector voltage 0800 Negative Detector voltage 1000 LED current 2000 Analog ground 4000 LED drive voltage 8000 Sensor ID

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Section 9

Manufacturer’s Declaration on EMC

9.1 Electromagnetic emissions

9.2 Recommended separation distances between portable and mobile RF communications equipment and the EUT

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9.3 Electromagnetic immunity

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Product Name

Convenient Infant Inc ubator

Model Name

BT-500

Serial No.

Warrant y Period

2 Y ears

Date of Purchase

Hospital:

Sales Agency

Manufacture

Bistos Co., Ltd.

Product Warranty

Address:

Customer

※ Thank you for purchasing BT-500. ※ This product is manufactured and passed through strict quality control and inspection. ※ Compensation standard concerning repair, replacement, refund of the product complies

with “Framework Act on Consumers” noticed by Fair Trade Commission of Republic of Korea.

Name: Telephone:

Service Telephone and Fax. Numbers

Telephone: +82 31 750 0340

Fax: +82 31 750 0344

FL., A Bldg., Woolim Lions Valley 5-cha, 302,

Galmachi-ro, Jungwo n-gu, Seongnam-si,

Bistos Co., Ltd.

Gyeonggi-do, Korea

www.bistos.co.kr

bistos@bistos.co.kr

Obelis s.a

Bd. Général Wahis 53

1030 Brussels, BELGIU M

Telephone: + (32) 2. 732.59.54

Fax.: + (32) 2.732.60.03